# K945847: Frialit (R)-2 Stepped Screw with Deep Profile Surface

- Pathway: 510(k) (Traditional)
- Applicant: Friatec Medical Inc., USA
- Decided: Mar 15, 1996 after 471 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
570 later devices descend from it; 2 cite it directly.
0 of 571 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K013067: Frialoc Dental Implant System (2002), 568 descendants of its own
- K021318: Xive Dental Implant System (2002), 547 descendants of its own
- K032158: Xive Dental Implant System Multiple (2003), 542 descendants of its own
- K024004: Xive Transgingival Dental Implant System (2003), 425 descendants of its own
- K032284: Xive TG Dental Implant System (2003), 394 descendants of its own

Source page: https://510kreport.com/device/K945847
Methodology: https://510kreport.com/methodology